For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Testosterone and NTx.

Device Description

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products Calibrators, which are combined by the VITROS Immunodiagnostic System to perform a VITROS assay).
1. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
1. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310).

The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.

AI/ML Overview

The provided text describes a 510(k) pre-market notification for VITROS Immunodiagnostic Products Testosterone Range Verifiers and NTx Range Verifiers. The submission aims to demonstrate substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, a detailed study proving performance against acceptance criteria, or most of the requested information about test sets, expert adjudication, or training sets for a device utilizing AI.

The device in question is a "Range Verifier," which is used to verify the calibration range of an immunodiagnostic system. This is a quality control product, not an AI-powered diagnostic device. Therefore, the questions related to AI-specific performance, human reader improvement, and extensive data set details are not applicable or not present in the provided text.

Based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria for performance (e.g., sensitivity, specificity, accuracy) because it is a range verifier, not a diagnostic test. Its performance is demonstrated by its "substantial equivalence" to a predicate device based on its characteristics and intended use.

Acceptance Criteria (Inferred from "Substantial Equivalence")	Reported Device Performance
Intended Use	For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Testosterone and NTx. (Matches predicate in function, differs in specific analytes verified)
Matrix of Range Verifiers	A base matrix of freeze-dried human plasma or buffered matrix spiked with analyte (Testosterone, NTx). (Similar to predicate: freeze-dried human plasma spiked with human pituitary FSH)
Range Verifier levels	Low and high (Matches predicate)
Safety and Effectiveness	The data presented provides a reasonable assurance that the VITROS Testosterone and NTx Range Verifiers are safe and effective for the stated intended use, demonstrated through comparison to a legally marketed predicate device.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided for this type of device. The document mentions "data presented in the pre-market notification" but does not detail a specific test set, its size, or provenance for performance evaluation in the context of sensitivity/specificity that would be relevant for a diagnostic or AI device. The equivalence is primarily based on device characteristics and intended use comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. The device is a range verifier, not a diagnostic interpretation tool, so "ground truth" in the clinical diagnostic sense with expert review is not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a quality control product for an immunoassay system, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly stated in terms of a clinical ground truth. The "ground truth" for a range verifier would be its ability to correctly verify the expected range of the VITROS Immunodiagnostic System. This would be established by the manufacturer through internal quality control and analytical validation, ensuring the spiked analytes are at known concentrations and that the verifier performs consistently within established tolerance limits for its intended purpose. The document primarily focuses on demonstrating equivalence to another verifier product.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/machine learning model.

9. How the ground truth for the training set was established

Not applicable.

Summary

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NOV 3 1998

Appendices

510(k) Summary (Appendix A)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is: 983513 .

1. Submitter name, address, contact

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester. New York 14626-5101 (716) 453-3607

Contact Person: Anne Zavertnik

Date 510(k) prepared: September 21, 1998

2. Device Name

Trade or Proprietary Name: VITROS Immunodiagnostic Products Testosterone Range Verifiers; VITROS Immunodiagnostic Products NTx Range Verifiers.

Common Name: Range Verifiers

Classification Name: VITROS Range verifiers for use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Testosterone and NTx.

3. Predicate Device

The VITROS Immunodiagnostic Products Testosterone and NTx Range Verifiers are substantially equivalent to VITROS Immunodiagnostic Products FSH Range Verifiers (K973517).

4. Device Description

The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products Calibrators, which are combined by the VITROS Immunodiagnostic System to perform a VITROS assay).
  Continued on next page

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510(k) Summary (Appendix A), Continued

1. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
1. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310).

The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.

5. Device Intended Use

For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Testosterone and NTx.

6. Comparison to Predicate Device

The VITROS Immunodiagnostic Products Range Verifiers are substantially equivalent to VITROS FSH Range Verifiers (predicate device), which was approved by FDA (K973517) for IVD use.

Table 1 lists the similarities and differences of the device characteristics between the VITROS TESTOSTERONE Range Verifiers with the predicate device, VITROS FSH Range Verifiers.

Continued on next page

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510(k) Summary (Appendix A), Continued

DeviceCharacteristic	VITROSRange Verifiers	PredicateDevice
Intended use	For use in verifying thecalibration range of theVITROSImmunodiagnostic Systemwhen used for themeasurement of aparticular analyte (see page6 for a list of analytes).	For use in verifying thecalibration range of theVITROSImmunodiagnosticSystem when used for themeasurement of FSH.
Matrix of Range Verifiers	A base matrix of freeze-dried human plasma orbuffered matrix spikedwith analyte (see page 6for full details).	A base matrix of freeze-dried human plasmaspiked with humanpituitary FSH.
Range Verifier levels	Low and high	Low and high

Table 1 List of the assay characteristics

7. Conclusions

The data presented in the pre-market notification demonstrate that the VITROS Testosterone and NTx Range Verifiers are substantially equivalent to the predicate device, for which there is FDA clearance.

Equivalence was demonstrated by comparing the physical properties and intended uses of these devices with commercially available reagents.

The data presented in the premarket notification provide a reasonable assurance that the VITROS Testosterone and NTx Range Verifiers are safe and effective for the stated intended use.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and have a simple, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the profiles.

3 1998 NOV

Ms. Anne Zavertnik Regulatory Affairs Associate Ortho-Clinical Diaqnostics A Johnson & Johnson Company 100 Indiqo Creek Drive Rochester, New York 14626-5101

K983513 Re: VITROS Immunodiagnostic Products Range Verifiers Trade Name: Requlatory Class: I Product Code: JJY Dated: October 6, 1998 Received: October 7, 1998

Dear Ms. Zavertnik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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Page 2

This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Intended Use (Appendix C)

510(k) Number (if known):	K983513
Device Name:	VITROS Immunodiagnostic Products Range Verifiers
Indications for Use:	For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Testosterone and NTx.

Page 1 of 1### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	OR	(Division Sign-Off)
------------------------------------------	------------------------------------------	---------------------

Division of Clinical Laboratory Devices

510(k) Number	K983513
Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.